Overview

The Effects of GLP-1 in Maturity-Onset Diabetes of The Young (MODY)

Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the treatment potential of GLP-1-analogues in patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborators:
Novo Nordisk A/S
University of Copenhagen
Treatments:
Glimepiride
Liraglutide
Criteria
Inclusion Criteria:

- Caucasian above 18 years of age

- Well characterised MODY3

- Body mass index (BMI) > 19 kg/m2

- Normal haemoglobin (males > 8.2 mM, females > 7.2 mM)

- Normal blood pressure (< 160/100 mmHg)

- Informed consent

- Capability to perform a light cycling test (heart rate 100-120 beats per minute during
30 minutes)

- Females: use of anticonception (IUC or hormonal)

Exclusion Criteria:

- Heart failure: New York Heart Association class III-IV

- Uraemia, end-stage renal disease, or any other cause of impaired renal function with
s-creatinine > 130 µM and/or albuminuria

- Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase
(ASAT) > 2 × upper normal serum levels)

- Anaemia

- Acute or chronic pancreatitis

- Stroma or thyroid cancer

- Pregnancy or breast feeding

- Inability to complete the study

- Treatment naïve patients with HbA1c < 7.0 %

- Treatment with medicine that can not be paused for 12 hours

- Known allergic reaction to study medication

- Intention to become pregnant

- Unwillingness to complete the protocol